The FDA and Health and Human Services (HHS) have announced that sotrovimab is no longer authorized for use to treat COVID-19 in any US region as it is unlikely to be effective against the Omicron BA.2 subvariant, which is now estimated to account for >50% of COVID-19 cases in the US.
Further information may be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization and https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Sotrovimab/Pages/default.aspx.
In Canada, Health Canada has announced that sotrovimab is unlikely to maintain efficacy against the Omicron BA.2 subvariant, and health care professionals are advised that local epidemiology and individual exposure to variants should be taken into consideration before use of sotrovimab.
Further information may be found at https://recalls-rappels.canada.ca/en/alert-recall/sotrovimab-injection-risk-treatment-failure-due-circulation-sars-cov-2-omicron-ba2.
COVID-19, mild to moderate (off-label use):
Note: Reserve for patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease or hospitalization; refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease. Use is not authorized for patients who are hospitalized or require new or increased oxygen therapy due to COVID-19; outcomes may be worse if used in patients requiring high-flow oxygen or mechanical ventilation (FDA 2022; IDSA [Bhimraj 2021]; NIH 2022).
IV: 500 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 7 days of symptom onset (FDA 2022). Note: Consider local prevalence of SARS-CoV-2 variants when evaluating treatment options (FDA 2022; IDSA [Bhimraj 2021]; NIH 2022). Further information may be found at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html.
No dosage adjustment recommended (FDA 2022).
There are no dosage adjustments provided (has not been studied) (FDA 2022).
(For additional information see "Sotrovimab (United States: Distribution paused; refer to 'Special Alerts' field): Pediatric drug information")
Note: Consider local prevalence of SARS-CoV-2 variants when evaluating treatment options; sotrovimab is not authorized for use in geographic regions where infection is likely to be due to a nonsusceptible variant (FDA 2022). Further information on variants may be found at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html.
COVID-19, mild to moderate:
Note: Only for use in patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease or hospitalization; refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease.
Children ≥12 years and Adolescents weighing ≥40 kg: IV: 500 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 7 days of symptom onset. Note: Sotrovimab has not been studied in pediatric patients; emergency use authorization from the FDA is based on likelihood of similar exposures in patients ≥12 years of age weighing ≥40 kg (FDA 2022).
Altered kidney function: Children ≥12 years and Adolescents weighing ≥40 kg: IV: No dosage adjustment recommended (FDA 2022).
There are no dosage adjustments provided in the fact sheet for health care providers (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous [preservative free]:
Generic: 500 mg/8 mL (8 mL [DSC])
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 500 mg/8 mL (8 mL)
Investigational agent; approved for emergency use authorization by the FDA May 2021.
Sotrovimab is not commercially available; it is available as part of ongoing clinical trials and under an emergency use authorization (EUA) from the FDA. The Department of Health and Human Services will determine weekly distribution amounts for each state/territory based on weekly reports of new COVID-19 cases and hospitalizations, in addition to data on inventories and use submitted to the federal government. State and territorial health departments will identify which sites in their respective jurisdictions receive product as well as the amount they will receive.
As part of the EUA, fact sheets pertaining to emergency use of sotrovimab are required to be available for health care providers and patients/caregivers, and certain mandatory requirements for sotrovimab administration under the EUA must be met as outlined in the FDA EUA letter; the fact sheets and EUA letter may be accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with sotrovimab use by either submitting a MedWatch form (https://www.fda.gov/medwatch/report.htm) or FDA Form 3500 (health professional) by mail or fax (1-800-FDA-0178); a copy of all MedWatch forms should also be provided to GlaxoSmithKline.
IV: If diluted solution is refrigerated prior to administration, allow solution to warm to room temperature for ~15 minutes prior to administration. Administer as an IV infusion over 15 minutes for 50 mL infusion bag or over 30 minutes for 100 mL infusion bag; administer through a PVC or polyolefin infusion set containing a 0.2-micron polyethersulfone filter. Due to potential overfill of prefilled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage. Slow or stop infusion and treat as appropriate if an infusion-related reaction occurs. Flush infusion line with D5W or NS following completion of infusion (FDA 2022).
Parenteral: IV: Must be diluted prior to administration. If diluted solution is refrigerated following preparation, allow solution to come to room temperature (~15 minutes) prior to administration. After priming with NS, administer as an IV infusion through a PVC or polyolefin (PO) infusion set; it is strongly recommended to use a 0.2 micron polyethersulfone filter. Infusion duration is dependent on size of infusion bag used:
50 mL infusion bag: Infuse over 15 minutes.
100 mL infusion bag: Infuse over 30 minutes.
Infuse the entire content of the bag to avoid underdosage; flush line with NS following completion of infusion. Slow or interrupt infusion and treat as appropriate if the patient develops any signs of infusion-associated events (eg, fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia, chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, diaphoresis); if severe or life-threatening hypersensitivity reactions occur, immediately discontinue infusion and provide emergency care (FDA 2022).
See “Use: Off-Label.”
COVID-19, mild to moderate
Hypersensitivity reactions, including anaphylaxis and infusion related reactions, have occurred with sotrovimab. Reactions may be severe or life threatening. Infusion related reactions may include arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, hypotension, hypertension, bronchospasm, difficulty breathing, altered mental status, angioedema, throat irritation, rash including urticaria, vasovagal reactions (eg, presyncope, syncope), among other reactions.
Mechanism: Immediate hypersensitivity reactions (eg, anaphylaxis): Non–dose-related; immunologic; IgE-mediated with specific antibodies formed against a drug allergen (Blumenthal 2019).
Onset: Immediate hypersensitivity reactions (eg, anaphylaxis): Rapid; IgE-mediated reactions generally occur within 1 hour of administration but may occur up to 6 hours after exposure (Blumenthal 2019, NICE 2014). Infusion related reactions: Rapid; occurred during the infusion and up to 24 hours after the infusion of sotrovimab.
The following adverse reactions and incidences are derived from the FDA issued emergency use authorization (EUA) unless otherwise specified. Refer to EUA for information regarding reporting adverse reactions (FDA 2022). Adverse reactions reported in adults.
Frequency not defined:
Dermatologic: Skin rash
Hypersensitivity: Anaphylaxis, hypersensitivity reaction (including severe hypersensitivity reaction), type 1 hypersensitivity reaction
Miscellaneous: Infusion related reaction (including severe infusion related reaction)
History of anaphylaxis to sotrovimab or any component of the formulation.
Canadian labeling: Hypersensitivity to sotrovimab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity: Serious hypersensitivity reaction, including anaphylaxis, may occur with administration of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care (FDA 2022).
• Infusion-related reactions: Infusion-related reactions (eg, fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia [eg, atrial fibrillation, sinus tachycardia, bradycardia], chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions [eg, presyncope, syncope], dizziness, diaphoresis) have been observed with administration of sotrovimab and up to 24 hours after the infusion. These reactions may be severe or life threatening. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care (FDA 2022).
• Antiviral resistance: Development of SARS-CoV-2 variants with reduced susceptibility to sotrovimab may potentially increase risk of treatment failure; consider local prevalence of SARS-CoV-2 variants, if available, when evaluating treatment options (FDA 2022; NIH 2022).
• Appropriate use: Sotrovimab may only be administered in health care settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary (FDA 2022).
• Clinical worsening: Clinical worsening of COVID-19, including signs or symptoms of altered mental status, arrhythmia (eg, atrial fibrillation, bradycardia, tachycardia), fatigue, fever, hypoxia, or increased respiratory difficulty, has been reported after administration of SARS-CoV-2 monoclonal antibodies; some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to COVID-19 progression (FDA 2022).
• Limitations of use: Sotrovimab is not authorized for use in patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID related comorbidity. Benefit of treatment has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen therapy or mechanical ventilation (FDA 2022).
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Reproductive toxicity studies have not been conducted (FDA 2022).
Sotrovimab is currently available under FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19. Reproductive toxicity studies have not been conducted (FDA 2022).
Sotrovimab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Outcome data following maternal use of sotrovimab during pregnancy are limited (AlKindi 2022; Gupta 2022). The potential benefits or risks of in utero exposure to sotrovimab to the fetus are not known (FDA 2022).
The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID. Pregnant patients with symptoms may require ICU admission, mechanical ventilation, or ventilatory support (ECMO) compared to symptomatic nonpregnant patients. Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2022; NIH 2022).
In general, the treatment of COVID-19 infection during pregnancy is the same as in nonpregnant patients (NIH 2022). Monoclonal antibodies should not be withheld from pregnant patients when otherwise appropriate (ACOG 2022; NIH 2022). Pregnancy is one of the medical conditions listed in the EUA eligibility criteria for sotrovimab. Use may be considered in nonhospitalized, COVID-19–positive pregnant patients who have mild to moderate symptoms, especially patients with 1 or more additional risk factors (eg, BMI >25, cardiovascular disease, chronic kidney disease, diabetes mellitus) (ACOG 2022; FDA 2022; NIH 2022). According to the EUA, dose adjustments are not recommended for patients who are pregnant (FDA 2022). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.
Data collection to monitor pregnancy and infant outcomes following exposure to sotrovimab is ongoing. Pregnant and recently pregnant patients exposed to sotrovimab are encouraged to enroll in the pregnancy registry (1-800-616-3791 or https://covid-pr.pregistry.com).
Data collection to monitor maternal and infant outcomes following exposure to COVID-19 during pregnancy is ongoing. Health care providers are encouraged to enroll patients exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists (OTIS) pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/).
It is not known if sotrovimab is present in breast milk.
Sotrovimab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
Sotrovimab is currently available under FDA emergency use authorization (EUA) for the treatment of COVID-19. Dose adjustments are not recommended for patients who are breastfeeding. According to the EUA, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother (FDA 2022).
Lactating patients with 1 or more risk factors for severe illness from COVID-19 infection may be treated with monoclonal antibodies when otherwise clinically indicated. Breastfeeding does not need to be discontinued. Breast milk has not been found to contain infectious materials from SARS-CoV-2 and maternal infection is not a contraindication to breastfeeding; however, patients should take all precautions to avoid spreading the virus to the infant (eg, hand hygiene, mask wearing) and the infant should be quarantined with the mother; alternatively, breast milk can be expressed and fed to the infant by someone without confirmed or suspected COVID-19 (ACOG 2022).
Interim guidance is available from the CDC for the care of lactating patients who are diagnosed with COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/care-for-breastfeeding-women.html). Information related to COVID-19 and breastfeeding is also available from the World Health Organization (https://www.who.int/news/item/28-04-2020-new-faqs-address-healthcare-workers-questions-on-breastfeeding-and-covid-19).
Monitor for infusion-related reactions (eg, fever, chills, hypotension, rash, pruritus) and hypersensitivity/anaphylaxis during infusion and for 1 hour following infusion completion (FDA 2022).
Sotrovimab is a recombinant human IgG1k monoclonal antibody that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2. Sotrovimab inhibits an undefined step that occurs after virus attachment and prior to fusion of the viral and cell membranes (FDA 2022).
Pediatric: Clinical trials have not been performed; serum exposures in patients ≥12 years of age and weighing ≥40 kg are expected to be similar to those observed in adults (FDA 2022).
Solution (Sotrovimab Intravenous)
500 mg/8 mL (per mL): $315.00
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